Integrated glucose monitor and insulin injection pen with automatic emergency notification

ABSTRACT

An insulin injection pen and blood glucose monitoring device is integrated into a single unit that fits in a user&#39;s clothing pocket or handbag. The device includes a blood glucose monitoring system for detecting the user&#39;s blood glucose level, an insulin injection mechanism, and a microprocessor that calculates an insulin dosage appropriate to the detected blood glucose level of a particular user and sets the insulin injection mechanism to administer the calculated insulin dosage. The device automatically informs a remote emergency service provider if the microprocessor determines that the detected blood glucose level presents a potential danger to the user. The microprocessor also calculates treatment regimens based on the detected blood glucose level and displays the treatment regimens on an LCD display. The device can include a GPS receiver that detects the location of the device, which is transmitted by the device to the remote emergency service.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to managing diabetes symptoms, and moreparticularly, to a device and method for controlling diabetes symptomsand monitoring a diabetes patient.

2. Description of Related Art

The prior art includes devices for monitoring blood glucose levels ofdiabetes patients and devices for administering insulin to control bloodglucose levels. Known blood glucose monitors take many forms. Forexample, one type of monitor is implanted in a patient and transmitsblood glucose readings to an external display more or less continuously.Other devices require the patient to take periodic blood samples foranalysis by the glucose monitor. In the latter type of device thepatient typically lances a finger and places a blood sample on a mediumsuch as a test strip. The monitor analyzes the test strip and provides adigital readout of the blood glucose level on a monitor display.

Depending on the patient's blood glucose level, it may or may not benecessary to administer a dose of insulin. Insulin delivery devices alsotake many forms. Broadly speaking, insulin delivery can be eitheressentially automatic by permanently attaching the patient to an insulinpump, or as-needed by using an injection device (such as a hypodermicneedle) with which the patient injects an amount of insulin determinedaccording to a predetermined protocol when the measured blood glucoselevel is outside an acceptable range.

Many devices and systems seek to automate diabetics' blood glucosecontrol protocols by computerizing conventional devices so that insulindosages can be automatically determined and delivered with minimumintervention by the patient. The following references illustrate sometypical examples of such devices and systems:

U.S. Pat. No. 4,731,726 U.S. Pat. No. 5,019,974 U.S. Pat. No. 5,536,249U.S. Pat. No. 5,593,390 U.S. Pat. No. 5,728,074 U.S. Pat. No. 5,822,715U.S. Pat. No. 5,840,020 U.S. Pat. No. 5,925,021 U.S. Pat. No. 6,192,891U.S. Pat. No. 6,544,212 U.S. Pat. No. 6,875,195 U.S. Pat. No. 6,906,802U.S. Pat. No. 7,427,275 U.S. Pat. No. 7,534,230 U.S. Pat. No. 7,591,801U.S. Publ. No. 2008/0306434 U.S. Publ. No. 2010/0010330 European. App.No. 1 102 194

Devices disclosed in U.S. Pat. No. 5,728,074 embody the “as-needed” typeof insulin delivery approach. Some of these disclosed devices could beparticularly useful because they provide a variety of functions that adiabetic would undoubtedly find helpful in managing his or her disease.For example, the disclosed embodiments include devices that combine aninsulin injection mechanism and a blood glucose monitor, such as the“pen-type injector” depicted in FIG. 25. This device has at one end aremovable cap that conceals a hypodermic needle for insulin injectionand a lancet mechanism used by the patient to prick a finger to obtain ablood sample for analysis by a test strip on the injector housing. U.S.Patent Pub. No. 2010/0010330 exemplifies the type of system that employsa blood glucose sensor implanted in the patient to provide continuousglucose level data to a bedside monitoring system that controls aninsulin infusion pump. The system can include software that determinesif the patient's blood glucose level is at a dangerously low level andcan alert 911 or other medical emergency response provider. While thisfeature enhances patient safety, it has a significant drawback in thatthe patient is tethered to the monitoring system.

Many diabetics lead relatively active lives, and for them being tetheredto a monitoring system is obviously not acceptable. These patientsrequire a treatment regimen that enables them to maintain a normallifestyle by minimizing limitations that might otherwise be imposed bytheir diabetes. Even though existing devices and systems permit suchpatients to closely monitor their own blood glucose levels, and thusminimize the risk of becoming hypoglycemic or hyperglycemic at any giventime, a diabetes patient still can experience either condition withoutmuch warning. Hypoglycemia can be particularly dangerous because it canimpair cognitive functions, so a patient with a low blood glucose levelcan become disoriented and confused very rapidly. If the patient's bloodglucose level is not corrected in time, he or she can lapse into a comaand even die before being able to take necessary corrective action. Bythe same token, hyperglycemia, while less likely than hypoglycemia topresent an emergency situation, can nonetheless be dangerous.Accordingly, devices that rely on the patient to take appropriate stepsafter determining his or her own blood glucose level would have greaterutility if they could automatically take action to preempt thepotentially serious consequences of rapid changes in blood glucoselevels.

SUMMARY OF THE INVENTION

It is an object of the present invention to improve on known techniquesinvolving self-administration of appropriate therapy to adjust glucoselevels after a patient tests his or her own blood glucose level. Oneimportant aspect of the invention provides an automatic alert to anemergency service provider if a patient using a device for self-testinghis or her own blood glucose level does not respond to prompts and thusmay be in need of immediate medical attention.

In accordance with a first aspect of the invention, a portable bloodglucose monitoring device and insulin injection pen integrated into asingle unit for testing and treating diabetes symptoms in a usercomprises a housing of a size suitable for transport in a handbag orclothing pocket of the user, a blood glucose monitoring system withinthe housing for receiving a sample of the user's blood and detecting theglucose level thereof, an insulin injection mechanism within the housingfor permitting the user to self administer an insulin injection, amicroprocessor within the housing for calculating an insulin dosageappropriate to the detected blood glucose level and setting the insulininjection mechanism to administer the calculated insulin dosage, adisplay mounted on the housing for displaying the detected blood glucoselevel and the calculated insulin dosage, and a communication devicewithin the housing and under the control of the microprocessor forautomatically informing a remote emergency service provider if themicroprocessor determines that the detected blood glucose level presentsa potential danger to the user.

In accordance with more specific embodiments of the invention, such aunit further comprises at least one manual input device operable by theuser in conjunction with information displayed on the display forproviding a user interface for permitting the user to controlpredetermined operations of the unit. A particularly advantageousembodiment comprises a GPS receiver within the housing for detecting thelocation of the device, wherein the communication device transmitsinformation regarding the location to the remote emergency service.

An additional aspect of the invention includes a method of monitoring adiabetes patient including providing a portable blood glucose monitoringdevice comprising a housing of a size suitable for transport in ahandbag or clothing pocket of the patient, the housing having therein ablood glucose monitoring system for receiving a sample of the patient'sblood and detecting the glucose level thereof, a storage device forstoring a threshold representing a blood glucose level of potentialdanger to the patient, a GPS receiver for detecting the location of thedevice, and a communication device for contacting a remote emergencyservice provider, introducing to the blood glucose monitoring system asample of the user's blood, comparing the detected blood glucose levelof the sample to the threshold blood glucose level, and if the detectedlevel is past the threshold, automatically activating the communicationdevice to transmit a message to the emergency service provider includinginformation on the potentially dangerous condition of the user andinformation regarding the location of the device.

In accordance with more specific method aspects of the invention, thestorage device stores a first threshold representing a blood glucoselevel below which the patient is severely hypoglycemic and may bedisoriented or comatose, and a second threshold above which the patientis severely hyperglycemic and may require immediate medicalintervention, and the method further includes setting a time period bywhich the patient must provide an input to the monitoring device if thedetected blood glucose level is below the first threshold or above thesecond threshold before automatically activating the communicationdevice. In another variation, the monitoring device further comprises aninsulin injection mechanism within the housing for permitting the userto self administer an insulin injection, and the method further includesdetermining if the detected blood glucose level indicates that thepatient is hypoglycemic or hyperglycemic, and if the patient ishypoglycemic, instructing the patient to ingest an amount of at leastone blood glucose producing substance based on the detected bloodglucose level, or if the patient is hyperglycemic, calculating aninsulin dosage appropriate to the detected blood glucose level and usingthe insulin injection mechanism to set an amount of insulin to beinjected based on the detected blood glucose level.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects of the invention will be better understood from the detaileddescription of its preferred embodiments which follows below, when takenin conjunction with the accompanying drawings, in which like numeralsand letters refer to like features throughout. The following is a briefidentification of the drawing figures used in the accompanying detaileddescription.

FIGS. 1A and 1B are perspective views showing the four sides of aunitary integrated blood glucose monitor and insulin injection penaccording to an embodiment of the present invention.

FIGS. 2A and 2B schematically depict a lancet and blood glucose teststrip that form a part of a blood glucose monitoring system that isintegrated into the blood glucose monitor and insulin pen unit shown inFIG. 1.

FIG. 3 partially depicts in schematic fashion an insulin injectionmechanism with a hypodermic needle that forms a part of the insulin penand blood glucose monitor unit shown in FIG. 1.

FIG. 4 is a simplified block diagram showing the system components foran blood glucose monitor and insulin pen unit according to oneembodiment of the present invention such as that shown in FIGS. 1 to 3.

FIG. 5 illustrates an embodiment of a user interface with an LCD displayand manual input devices incorporated into the unit shown in FIG. 1.

FIG. 6, comprising FIGS. 6A, 6B and 6C, is a flowchart depicting thesteps in a blood glucose test and insulin injection cycle according toan embodiment of the present invention.

FIG. 7 illustrates a display mode of the LCD display shown in FIG. 5 inwhich it can display numeric fields indicating a blood glucose level,insulin dosage, and other information.

FIG. 8 illustrates a display mode of the LCD display shown in FIG. 5 inwhich it can display messages to the user.

One skilled in the art will readily understand that the drawings are notstrictly to scale, but nevertheless will find them sufficient, whentaken with the detailed descriptions of preferred embodiments thatfollow, to make and use the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1A and 1B show an integrated blood glucose monitor and insulin penunit 10 in accordance with one embodiment of the invention. Theintegrated monitor/pen unit 10 has an elongated, generally rectangularhousing 12 most conveniently provided in a one-piece molded plasticconstruction. A cap 14 fits onto the housing 12 at one end to conceal ahypodermic needle (not shown in FIG. 1) that forms a part of an insulininjection mechanism described in more detail further below. The cap 14is also conveniently molded from a suitable plastic material in onepiece, and fits snugly onto the end of the housing 12 either by frictionor by a snap fit, to prevent inadvertent removal of the cap andconsequent exposure of the hypodermic needle. A blood glucose monitoringsystem 16 also includes a cap that fits snugly onto the other end of thehousing 12. Further details of the blood glucose monitoring system andthe insulin injection mechanism are described below in connection withFIGS. 2 and 3.

When the caps are in place on the housing 12, these parts together forma cylinder with a rectangular cross section that has substantiallyconstant dimensions along its entire length and has a unitaryappearance. The cross section can have rounded corners, which will givethe unit 10 a compact appearance and facilitate handling by a user. Theelongated configuration of the housing enables the various mechanicaland electronic components of the monitor/pen unit 10 to be contained ina compact device that is easily carried in a pocket or handbag/purse. Tothat end, a preferred unit will have a cross section about 1.0″×0.5″ andbe about 5″ to 6″ long. Other configurations and dimensions can be usedwithin the broadest scope of the invention. For example, one skilled inthe art may chose to arrange the internal components of the unitdiscussed below in a manner that makes it preferable to use a differentconfiguration or a different size.

The unit 10 further includes various components for receiving inputsfrom a user and communicating outputs to the user or to otherdestinations, as described further below. A speaker 18 enables the unitto provide voice commands or prompts to the user, and a microphone 20enables the user to communicate with the unit by voice. A USB port 22enables communications between the unit and associated peripheraldevices, as well as permitting uploading of information to a memory inthe unit and downloading information from the memory. On an adjacentside of the housing a removable cover 24 provides access to the insulininjection mechanism within the housing for purposes described below. Onthe same side, a battery compartment with a removable cover 26 acceptsbatteries of a suitable rating for providing operating power to theunit. The batteries can be rechargeable, and recharging can beaccomplished by attaching a suitable power cord to the USB port. Thisside of the housing 12 can be considered the rear of the unit since thecovers 24 and 26 are accessed relatively infrequently. The covers 24 and26 are placed on the longer side of the unit's rectangular cross sectionto facilitate their manipulation by a user. This side of the unit alsoincludes an ON-OFF switch 28 for powering the unit on and off. (Indescribing embodiments of the invention, terms indicating direction ororientation, such as “front,” “rear,” “right,” “left,” etc., may be usedto facilitate the description. They do not imply that the invention islimited to a particular orientation of the pen/monitor unit.)

FIGS. 2A and 2B are schematic representations of an exemplary embodimentof the blood glucose monitoring system 16. FIG. 2B shows a lancet 30extending from the inside of a glucose monitoring system cap 32 thatfits snugly on the end of the housing 12 as discussed above. The lancet30 is essentially a very sharp needle typically made of surgical gradestainless steel. The patient pricks a finger with the lancet to draw asufficient quantity of blood for glucose level testing. FIG. 2A showsthe end of the housing 12 from which extends a glucose test strip 33onto which the user places a blood sample by touching the lanced fingerto the strip. The strip then introduces the blood by capillary actioninto conventional testing apparatus within the unit that determines theblood's glucose level. The details of the glucose level testing do notform a part of the present invention, and are well known to thoseskilled in the art. U.S. Pat. No. 5,728,074 mentioned above describesvarious ways of performing such testing and obtaining a correspondingelectrical signal. Any of those techniques, or variations thereof, canbe used in performing blood glucose testing with the unit 10, and thoseportions of U.S. Pat. No. 5,728,074 describing such testing areincorporated by reference as if set out in full herein. Many of theother patents discussed above also describe ways of testing bloodglucose levels, and unit 10 could use any of those techniques as well.

Although the manner in which the patient's blood glucose level isdetermined is conventional, the configuration of the blood glucosetesting system 16 shown in FIGS. 2A and 2B is particularly advantageousfrom the standpoint of a user of the unit 10. The cap 32 has an internalshoulder 34 that fits over a corresponding external shoulder 36 on thehousing 12. The internal shoulder 34 includes a circumferential groove34 a that accepts a circumferential ridge 36 a on the external shoulder36. The groove 34 a and ridge 36 a provide a snap fit to positively holdthe cap 32 on the housing 12 The outside peripheral surfaces of the cap32 and housing 12 are flush in order to maintain the unitary appearanceof the unit 10 when the cap is in place on the housing. A lancet 30 andtest strip 33 are each typically used only once and then discarded. Thecap 32 can be made hollow to store sterile lancets, which are accessibleto a user by making an interior panel 40 in the cap removable. Teststrips may be stored in a cartridge in the unit and dispensed one at atime by a slider button on the side of the unit (not shown). The end ofthe unit may be made removable to enable replacement of empty test stripcartridges. Those skilled in the art will recognize many ways in whichthe blood glucose monitoring system can be implemented while stillmaintaining the sleek, compact appearance of the unit 10 that comprisesan aspect of the invention.

FIG. 3 shows an exemplary embodiment of an insulin injection mechanism50. The insulin injection mechanism includes a cap 14 as shown in FIGS.1A and 1B to protect the hypodermic needle 52 from damage and to preventinadvertent needle sticks. The cap is not shown in FIG. 3. As with thecap 32, the cap 14 of the insulin injection mechanism fits snugly ontothe end of the housing in a manner similar to that used for the cap 32.That is, the housing 12 presents an external shoulder 54 with acircumferential ridge 54 a. The external shoulder 54 fits into aninternal shoulder on the cap 14 (not shown) to hold the cap 14 in placeon the housing in a manner similar to that described above for the cap32. The outside peripheral surfaces of the cap 14 and housing 12 areflush in order to maintain the unitary appearance of the unit 10 whenthe cap is in place on the housing. U.S. Pat. No. 5,728,074 mentionedabove describes various ways of implementing an insulin injectionmechanism. Any of those mechanisms, or variations thereof, can be usedin the unit 10 of the present invention, and those portions of U.S. Pat.No. 5,728,074 describing insulin injection mechanisms are incorporatedby reference as if set out in full herein. Many of the other patentsdiscussed above also describe insulin injection mechanisms, and any ofthose mechanisms can be used in the unit 10 as well. If the user has togain access to the interior components of the insulin injectionmechanism for any reason, such as to replace a cartridge containingplural insulin doses, the cover 24 can be removed to provide suchaccess.

Referring back to FIG. 1A, the side of the housing 12 opposite the sidehaving the insulin injection mechanism access opening 24 and the batterycompartment 26, can be considered the front of the unit. It has a userinterface that comprises two manual input devices 102 and 108 and an LCDdisplay 200. The manual input device 102 is a circular touch-activateddevice in which each of four regions separated by 90° provide an inputsignal when touched by a user. Touching a center region provides aSELECT command. The input device 108 acts a mode switch by which theuser can set a mode of operation of the device by moving an image of aslider to the right or left. A more detailed description concerning thelayout and operation of the input devices is provided below inconnection with FIG. 5. These devices, together with the LCD display200, enable operation of the device as described in detail below. Theseinput devices can take alternate forms, such as mechanical switches thatclose respective electrical circuits when pressed. They can also havedifferent configurations, and be located on the unit 10 in locationsother than as depicted in the accompanying drawings. In its broadestaspects, the invention includes all manner of input devices capable ofproviding the desired control functions. The LCD display 200 is capableof displaying different screens, depending on the input from the manualinput devices or the unit's controlling software. The LCD display can bebacklit with different colors for purposes described in more detailbelow. Those skilled in the art will recognize that other types ofdisplay devices can be used within the scope of the invention. A morecomplete description of the user interface is deferred until thediscussion further below of the operation of the unit 10 and itsimproved manner of enabling diabetes patients to more easily and safelymanage their symptoms.

FIG. 4 shows the system components for providing the operating functionsof the unit in accordance with particular embodiments of the invention.The unit is under the overall control of a microprocessor 300 thatincorporates a read-only memory ROM storing an operating system andexecutable programs that use algorithms and data provided to the unit todetermine insulin dosages and other parameters useful in managing thepatient's symptoms, and that control the operation of the various othercomponents of the system described just below. The microprocessor 300also includes a random access working memory RAM to enable themicroprocessor to execute programs stored in the ROM. A clock 302 in thehousing 12 is under the control of the microprocessor 300. The clockprovides time and date information to the microprocessor for display onthe LCD display, as discussed below. The microprocessor 300 can alsocondition the clock 302 to function as a timer for providing elapsedtime data to the microprocessor for purposes also discussed below.

In the present embodiment the unit 10 further includes Wi-Fi circuitry304 in the housing 12 and under the control of the microprocessor 302.The Wi-Fi circuitry can communicate with remote locations via wirelessconnection to the Internet if the unit 10 is sufficiently close to aWi-Fi router. This enables information to be sent and received by theunit wirelessly at very high speeds. The unit 10 further includes a GPS(Global Positioning System) receiver 306 that receives signals from aGPS satellite to indicate the global longitude and latitude of the unit.The unit can also include Bluetooth circuitry 308 for wirelessconnection to a peripheral device such as a user's cellular telephone orpersonal digital assistant (not shown). Finally, the present embodimentalso includes an internal cellular telephone 310 for dialing remotelocations under the control of the microprocessor 300. The cellulartelephone can further include so-called 3G or 4G circuitry forconnection to the Internet when connection to a Wi-Fi router connectioncannot be made. The functions and purposes of these components arediscussed below in connection with the operation of the unit 10.

FIG. 5 is a detailed view of the front of the unit 10, showing thelayout of the manual input devices 102 and 108 and the LCD display 200.The four regions spaced at 90° around the periphery of thetouch-activated input device 102 provide separate input functions. AMENU “button” 102 a at a nine o'clock position on the circular device102 causes a menu of control options to be displayed on the LCD display200. An UP “button” 102 b at twelve o'clock and a DOWN “button” 102 c atsix o'clock on the device 102 enable the user to scroll through andhighlight menu choices shown on the LCD display. The center of thedevice 102 comprises a touch-activated SELECT “button” 102 d thatselects the highlighted choice. The region at three o'clock is aDATE/TIME “button” 102 e that causes the LCD display 200 to indicate thedate 202 and the time of day 204, as shown in FIG. 5. The LCD displayalso includes a battery status indicator 206 that indicates in aconventional manner the amount of battery life remaining. The unitdefaults to the date/time display in the absence of other inputs to thedevice 102. The mode switch 108 has an image of a slider 108 a that actsas a switch “button.” Unit software maintains the slider image in adefault position midway between the right and left ends of the imagedisplay that comprises the input device 108. A user slides the button tothe right (as seen in FIG. 5) to activate the glucose monitoring system16 and to the left to activate the insulin injection mechanism 50. Theunit may also include a separate button (not shown) that “locks” thedevices 102 and 108 so that they cannot be inadvertently actuated. Theuse of the input devices and the LCD display to operate the unit isdiscussed in more detail as part of the following explanation of how oneembodiment of the unit is typically used to manage the symptoms of adiabetes patient.

Initialization of the Unit

To perform the tasks described herein, the unit 10 requires initial setup by inputting data from the patient's healthcare provider. In its mostbasic form, this involves loading data into the ROM in the devicemicroprocessor 300 that will enable the programs stored therein tocalculate insulin dosages and specify treatment regimens based on theuser-patient's tested glucose level. This data can be input using aportable USB drive (not shown) on which the necessary information hasbeen stored by the healthcare provider and which is then plugged intothe USB port 22, or by sending the information to the unit over theInternet via a receiver included in the Wi-Fi circuitry 304 or thecellular telephone circuitry 310 included in the unit.

The necessary data is loaded into the unit's ROM by the healthcareprovider so that it is available when the patient uses the unit. Thedata would typically include information such as insulin dosages andtypes and amounts of glucose-producing substances to be consumed basedon tested blood glucose levels, and any other data or parametersrequired by the algorithms in the ROM used by the device to determine agiven insulin dosage or amount and type of glucose-producing substanceto be ingested appropriate to a patient's tested blood glucose level.The exact nature of this data does not form a part of the presentinvention, and literature such as the references already discussed aboveillustrate the type of data that can be used in this regard. The dataloaded into the unit also includes at least four blood glucose levelsfor the particular patient-user:

-   -   L1: Threshold level for severe hypoglycemia    -   L2: Threshold level for mild hypoglycemia    -   L3: Threshold level for mild hyperglycemia    -   L4: Threshold level for severe hyperglycemia

The description that follows of a testing/treatment/emergencynotification process using the unit of the present invention assumesthat a treatment protocol with the necessary information appropriate tothe particular patient using the unit has been stored in the unit ROM.

One way of uploading the necessary data to the unit uses the inputdevice 102 and the LCD display 200 under the direction of themicroprocessor 300. For example, in one possible embodiment the MENUregion 102 a of the input device 102 would be touched when data was tobe uploaded to the unit 10. The microprocessor could be programmed toprompt insertion of a USB drive into the USB port 22 if that had notalready been done, and then to cause the LCD to display a menu ofprompts that a user can scroll through using the UP and DOWN buttons 102b and 102 c to highlight displayed prompts in order. For example, a menucould include a number of options, one of which is “INPUT DATA.” The UPand DOWN buttons would enable the user to highlight that option andactivation of the SELECT button 102 d would cause the data to beuploaded into the unit. Any other prompt menus necessary at varioustimes during a data upload could be displayed and chosen in the samefashion.

Another menu item could permit the user to choose the language in whichthe unit will display messages and provide voice prompts during use ofthe unit for blood glucose monitoring and insulin injection. Forexample, one of the menu choices could be LANGUAGE, and once that menuitem is highlighted by scrolling to it using the UP or DOWN button,touching the SELECT region 102 d causes the LCD display to list theavailable languages. Again, the UP or DOWN button is used to scroll toand highlight the desired language choice, and the SELECT region 102 dis touched to select the highlighted language choice. Typically, thedefault language will be English, and messages and voice prompts will bein English unless changed.

Using the Unit for Blood Glucose Testing and Insulin Injection

FIG. 6 is a flowchart depicting the manner in which the unit 10 operatesto perform a testing/treatment/emergency notification process accordingto one embodiment of the invention. It will be understood that the stepsshown in the flowchart of FIG. 6 are under the control of applicationsoftware stored in the ROM in the microprocessor 300 and executed by themicroprocessor 300 in a conventional fashion. Any suitable programminglanguage or technique can be utilized to carry out the steps depicted inFIG. 6 or their equivalents, and the invention is not limited to anyparticular software configuration.

A patient initiates a blood glucose test in step S102 by sliding themode switch button image 108 a to the right as seen in FIG. 5 to the“TEST BLOOD” mode of operation. This sets a flag F to “0” in step S104and sets a timer in step S105 to count down a sufficient time for theuser to perform a blood glucose test as described below in connectionwith step S106. A suitable time period is preferably about five minutes,but can be any appropriate time period between, say, three minutes and10 minutes.

At the same time, the microprocessor 300 causes the LCD display 200 todisplay the screen 208 shown in FIG. 7. This screen includes the batterystatus indicator 206, so that the user always has a visual indication ofhow much charge remains in the unit's batteries. It further includes anicon 210 that indicates the status of the blood testing procedure, threenumeric fields 212, 214 and 216, and two text fields 218 and 220. Asseen in display status box D102, the blood test status icon 210 isflashing and the first text field 218 contains the message “AWAITINGBLOOD SAMPLE.” The numeric fields all display the numeral “0” and thesecond text field 220 is blank. (The dotted lines denoting the numericand text fields in FIG. 7 indicate the positions of the fields on thedisplay; the dotted lines are not part of the display.) A star-shapedalarm icon 222, described in more detail below, is not visible in thedisplay indicated by the display status box D102. The microprocessor 300can be further programmed to provide a voice message to the speaker 18that repeats the message displayed in the first text field 218. Thecapacity to echo a text message with a voice prompt can be an importantfeature because impaired vision or even blindness can be a side effectof diabetes.

The unit then waits at step S106 for the patient to take a blood sampleand initiate a blood glucose level test. To take a blood sample, thepatient removes the cover 32 from the blood glucose monitoring system 16(see FIG. 2), retrieves a lancet 30 from inside the cap 32, affixes itto the cap, and pierces a finger using the lancet 30. As described abovein connection with FIG. 2, the patient places a blood sample on the teststrip 33, which the user has extended from a cartridge within the unithousing 12. When the blood sample reaches the glucose sensing componentswithin the unit 10, the icon 210 stops flashing and is lit continuously,while the first text field 218 contains the message “TESTING GLUCOSELEVEL” (not shown in FIG. 6). During the time elapsed after the timer isset in step S105, the microprocessor continuously checks to see if thetimer has timed out. This is represented by the loop including stepsS106 and S108. As before, the microprocessor 300 can be programmed toprovide a voice message to the speaker 18 that repeats the messagedisplayed in the first text field 218. If the timer times out before theunit detects the presence of a blood sample, the process terminates, asshown at step S110. This causes the unit to go into a “sleep” mode tosave battery life. Any suitable manner of “waking” the device can beused. For example, in the sleep mode the LCD display would be off, buttouching either input device 102 or 108 could cause the display of amessage that touching the DATE/TIME region 102 e will activate the unit.

Blood Test Results Indicate Hypoglycemia

If the microprocessor detects a blood sample before the timer times out,the process proceeds to step S112, which initiates an important aspectof the invention. As noted above, the microprocessor ROM stores datarelating to normal blood glucose levels particular to the patient usingthe unit, as well as certain predetermined levels that indicatedifferent blood glucose readings that the patient can safely tolerate.In step S112 the microprocessor determines if the tested blood glucoselevel is below the critical predetermined level L1 that indicates severehypoglycemia and could result in the imminent onset of diabetic coma inthis particular patient. If so, another time period is set in step S114.At the same time, the LCD display 200 displays the blood glucose levelin the numeric fields 212, 214 and 216, and the first text field 218 nowreads “BLOOD GLUCOSE LEVEL.” The display can optionally indicate theunits in which the blood glucose level is displayed, but in a preferredembodiment the level is expressed in the standard units of mg/dL and noindication of the units is necessary. If the blood glucose level is lessthan L1, the LCD display is back lit in flashing red, the star-shapedalarm icon 222 begins flashing red to indicate a severe hypoglycemiccondition, and the second text field 220 is changed to read “PRESS ANYBUTTON,” as seen in display status box D104. The microprocessor alsosends to the speaker 18 an audible prompt such as, “To terminate alarmcondition press any button on the unit or say “OK.”

During the time elapsed after the timer is set in step S114, themicroprocessor continuously checks to see if the timer has timed out.This is represented by the loop including steps S116 and S118. Asuitable time period is about 10 seconds, and is preferably not morethan one minute. The purpose of this time period is to give the user anopportunity to respond in a manner that indicates that the user has notbecome disoriented, or even entered a diabetic coma, because of theindicated severe hypoglycemia detected by the blood test. If theuser-patient presses anyplace on the input device 102, or the microphone22 picks up an audible signal that voice recognition software in themicroprocessor recognizes as “OK,” before this time period expires, themicroprocessor proceeds to the next portion of the process, discussedfurther below.

However, if the timer times out before the patient responds, the unit 10responds at step S120 with an automatic call using the unit's internalcellular telephone 310 to call a public emergency service provider bydialing 911 and to call a pre-subscribed emergency service such as theAlert One® medical alert service provided by Alert One Services, Inc.,of Williamsport, Pa. The unit sends a prerecorded message to 911 and tothe subscriber service that identifies the caller, states that he or shemay be in a diabetic coma, and includes information on the unit'slocation provided by the GPS receiver 306. The unit's ROM can includesoftware and a database for converting the unit's global coordinatesprovided by the GPS receiver 306 into usable location information, suchas a street address, but the capability of converting the coordinatesinto location information can also be at the call reception location, orvia a handheld device such as an Apple iPhone® with which the unitcommunicates via its Bluetooth circuitry 308. In the latter case, thecall to the emergency service provider can be made by the externaldevice, as well. Communicating with both 911 and a private subscriberservice ensures that the patient will obtain the medical attentionnecessary because of his or her severe hypoglycemia.

The automatic notification of 911 and/or an emergency subscriber serviceis an important aspect of the invention. One of the objects of thepresent invention is to enable a diabetic patient to maintain alifestyle that is as normal as possible, while still managing thesymptoms of his or her diabetes. To do that, the user must have a levelof confidence that a self-monitoring device can reduce the chances fornegative outcomes if his or her symptoms should become so severe thatthey present a serious, or even life-threatening, situation. Byproviding for automatic notification of an emergency service provider(“911” and/or a subscriber service) as discussed herein, the unit 10gives the user-patient confidence that symptoms that are so severe thathe or she may not even be able to recognize their existence, willautomatically engender an emergency response and immediate emergencytreatment or other appropriate action. The other instances discussedbelow in which the unit 10 performs automatic emergency notificationsachieve the same effect.

Returning to step S112, if the tested blood glucose level is higher thanthe level L1, the process proceeds to step S122, where the level is nowcompared to the predetermined minimum level L2 for the particularpatient for whom the unit has been set up. A blood glucose level belowL2 indicates that the patient is mildly hypoglycemic and needs toincrease his or her blood glucose by ingesting a suitable blood glucoseproducing substance. To that end, the microprocessor sets the LCDdisplay 200 as indicated in display status box D106, with the LCDsteadily back lit in a different color, such as red, to indicate ahypoglycemic condition, with the star-shaped alarm icon 222 illuminated,and with the message “GLUCOSE LEVEL LOW” in the second text field 220.At the same time, the microprocessor sets another time period in stepS124, for a purpose described further below. As indicated in the figure,the process also proceeds to step S124, after setting the flag F=1 instep S126, when the unit detects a user response from a severelyhypoglycemic patient (step S116).

Next, the process checks the status of the flag F in step S128. If F=1,indicating a severe hypoglycemic condition, the LCD display 200 changesto the mode shown in FIG. 8 to display a treatment regimen to the user.This screen 230 includes a first text field 232 and a second text field234, corresponding to the first and second text fields of screen 208shown in FIG. 7. The numeric fields of screen 208 are replaced by amessage field 236, which is capable of displaying treatment instructionsto the patient-user. (As with screen 208, the dotted lines in screen 230shown in FIG. 8 denoting the text and message fields indicate thepositions of the fields and are not part of the display.) Text field 232now reads “LOW GLUCOSE LEVEL,” indicating that the patient needs toingest a carbohydrate-containing substance. In accordance with knowntreatment protocols, the type of substance will generally be in thenature of a sugary drink, such as a commercially available fruit juice,a solid food containing sugar and/or other carbohydrates, or a glucosegel available for the express use of diabetic patients. The amount ofthe substance will reflect that the patient's blood glucose level is ata dangerously low level less than L1 (see steps S112 and S126).According to one standard protocol, the unit software causes the messagefield 236 to display treatment regimen instructions such as shown indisplay status box D108:

-   -   Drink 8 oz. sugary drink AND        -   Eat 3 graham crackers, OR        -   Ingest 2 tubes glucose gel.

In addition, the second text field 234 reads “RETEST BLOOD IN 15 MIN.”This provides sufficient time for the patient's blood glucose level torespond to the ingestion of the prescribed substance(s). It will beunderstood by those skilled in the art that the particular substanceslisted here are representative and may be other substances within thescope of the invention. In addition, the 15-minute waiting time is alsorepresentative, and it too can be other time periods if deemedappropriate for a given patient. Indeed, the substances to be consumedand the waiting period between blood tests can be tailored to theindividual patient-user of the unit and stored in the unit ROM fordisplay as discussed here.

The time period set in step S124 allows for the waiting period justdiscussed, that is, 15 minutes in the present embodiment of theinvention, plus an interval that will allow sufficient time to take thenext blood test. In an alternate embodiment, the unit can first set a15-minute time period and then prompt the user to perform the next bloodtest by displaying a screen similar to that shown in display status boxD102 and/or generating an audible signal such as a repeating beepingsound. Then, another time period will be set as in step S105 with a timeperiod such as five minutes in which the user must perform the bloodtest. In any case, the microprocessor continuously checks to see if thetimer has timed out, as represented by the loop including steps S130 andS132.

If the patient fails to take another blood sample within the timeallotted, the unit 10 responds at step S134 with an automatic call usingthe unit's internal cellular telephone 310 to the subscriber servicesuch as the Alert One® medical alert service discussed above. The callidentifies the caller, states that he or she is not responding asrequired by his or her treatment protocol, and includes a prerecordedmessage that includes information on the unit's location provided by theGPS receiver 306. The subscriber service will then call the user to makea judgment as to whether or not emergency service is required. A call to911 is not made at this time since it is unlikely that the user is inimminent danger of entering a diabetic coma considering the amount ofblood glucose producing substances that have just been ingested.

In another alternate embodiment, the microprocessor can be programmed toawait the user's confirmation that the blood sugar producing substanceshave been ingested as instructed. That is, if the protocol incorporatesa first 15-minute period to allow for the ingestion of the substances asdirected by the unit, the user could be required by a message on the LCDdisplay 200 and/or an audible prompt to confirm that the specifiedsubstances were consumed before the second time period waiting for thenext blood test is set. If the user does not respond as directed, theprocess would go to step S120. This embodiment would account for aseverely hypoglycemic patient who was able to respond in step S116, butnevertheless did not respond in time to the ingestion of the directedsubstances to prevent disorientation or coma.

If the unit receives the results of the second blood test before thetimer times out, the process advances to step S136, where the glucoselevel is again compared to L2. If the patient is still hypoglycemic(blood glucose level<L2), the process first proceeds to step S138 whereit increments the status of the flag by 1, so that F=2, and then returnsto the point where the LCD display 200 exhibits display status box D106,with the numeric fields 212, 214 and 216 now displaying the currentglucose level. Step S124 sets the same time period a second time and theprocess proceeds to step S128. Since F=2 (that is, F≠1), step S128directs the process to step S140, where it is determined if F=3.

It will be appreciated that if the first blood test taken in step S106resulted in a blood glucose level between L1 and L2, indicating milderhypoglycemia, the process will also reach step S140, since in that eventstep S128 will detect that F=0 (that is, F≠1). Step S140 then detectsF≠3, meaning that the LCD display 200 again changes to the mode depictedin FIG. 8. According to the treatment protocol represented by thepresent embodiment, the unit's software causes the message field 236 todisplay the following treatment instruction, as shown in display statusbox D110:

-   -   Drink 4 oz. sugary drink, OR        -   Eat 3 graham crackers, OR        -   Ingest 1 tube glucose gel

In addition, the second text field 234 reads “RETEST BLOOD IN 15 MIN.”This provides sufficient time for the patient's blood glucose level torespond to the substance(s) ingested to raise his or her glucose levels.The unit will now wait for the results of a second blood test, aseffected by the loop comprising steps S130 and S132. If a blood test isnot taken before the timer times out, the process proceeds to step S134,described above.

Severely Hypoglycemic Patient after the Second Blood Test.

If the second blood test for a severely hypoglycemic patient stillindicates a hypoglycemic condition, the amount of the substances thatwill raise the user's blood glucose levels is reduced from the amountthat was ingested after the first blood test. This is effected by thestatus of the flag F, which was set at F=2 after the second blood test.Step S128 now detects that F≠1 and advances the process to step S140,which detects that F≠3. Consequently, the LCD display issues theinstruction shown in display status box D110, instructing the patient toperform a third blood test, and then advances to step S130. If the thirdblood test indicates that the patient's glucose level is still less thanL2, step S138 sets the flag status F=3 (F=2+1), and returns the processto the point where the LCD display 200 exhibits display status box D106,with the numeric fields 212, 214 and 216 displaying the current glucoselevel. Step S124 sets the same time period again and the processproceeds to step S128. Now, F=3 (that is, F≠1), step S128 directs theprocess to step S140, which detects that F=3. This causes the unit toproceed to step S120, which is described above. In other words, theprotocol of the present embodiment assumes that the failure of thepatient's severe hypoglycemia to respond to the ingestion of largeamounts of glucose-producing substances indicates a possible emergencycondition and warrants a call to 911.

Mildly Hypoglycemic Patient after the Second Blood Test.

If the second blood test for a more mildly hypoglycemic patient stillindicates a hypoglycemic condition, the amount of the substances thatwill raise the user's blood glucose levels is increased from the amountthat was ingested after the first blood test. This is effected by thestatus of the flag F, which step S138 set at F=1 after the second bloodtest. Step S128 now detects that F=1 and the LCD display 200 displaysthe instruction in display status box D108 and waits for the results ofa third blood test, as effected by the loop comprising steps S130 andS132. In other words, the protocol of the present embodiment increasesthe amount of blood glucose producing substances to be ingested by thepatient because of his or her failure to adequately respond to theingestion of a smaller amount per the instruction in display status boxDUO. Assuming a third blood test is taken within the time allotted(steps S130 and S132), the process then determines if the user's bloodglucose level is now at least L2. (If a third blood test is not takenbefore the timer times out, the process proceeds to step S134, describedabove.)

If the third blood test indicates that the patient's glucose level isstill less than L2, step S138 sets the flag status F=2 (F=1+1). Theprocess returns to the point where the LCD display 200 exhibits displaystatus box D106, with the numeric fields 212, 214 and 216 displaying thecurrent glucose level.

The patient now can ingest additional blood glucose containingsubstance(s) and take a fourth blood test, since step S140 will detectthat the flag status F≠3. However, the patient may decide based onpersonal experience that the glucose level already achieved (asdisplayed in display status box D106) is acceptable, and elect not totake a fourth blood test. In that event, the timer times out, the unitcalls the subscriber service (step S134), and the patient can confirm tothe caller that he or she has an acceptable glucose level and does notneed assistance. However, if the user elects to take a fourth bloodtest, step S136 again determines if the tested glucose level is stillbelow L2. If so, step S138 sets the flag status F=3 (F=2+1), and whenthe process reaches step S140, it will detect that flag status andproceed to step S120, as discussed above. In other words, thisparticular protocol assumes that the patient requires emergencyassistance since the repeated ingestion of blood glucose producingsubstances has not remedied a detected hypoglycemic condition.

If at any time, step S136 detects a blood glucose level that is not lessthan L2, the process proceeds to step S142, where the flag status F isset to F=0, and then proceeds to step S144, which determines if theuser's blood glucose level is not above L3, thus indicating that is inthe normal range between L2 and L3. If so, the process terminates, asindicated in step S146 (similar to step S110). If step S144 indicatesthat the user's blood glucose level exceeds L3, it indicates ahyperglycemic condition, possibly requiring the administration of aninsulin injection. In addition, if the first blood test (step S106)indicates a blood glucose level that exceeds L2, the process alsoproceeds to step S144 (see steps S112 and S122). Step S146 can beaccompanied by a message on the LCD display 200 indicating that theuser's blood glucose level is normal, with the background of the displaylit in steady or flashing green, to provide an immediately recognizableindication that the user's glucose level is acceptable.

Blood Test Results Indicate Hyperglycemia

If step S144 indicates that the user's blood glucose level is above L3,the next step S148 determines if the level is above L4, thus indicatingmore severe hyperglycemia. If so, the process proceeds to step S150 tocheck the status of the flag F. Since the flag F was set F=0 (step S104or step S142), the process proceeds to step S152. At the same time, theLCD display 200 displays the blood glucose level in the numeric fields212, 214 and 216, and the first text field 218 now reads “BLOOD GLUCOSELEVEL.” The LCD display is back lit in flashing red, the star-shapedalarm icon 222 begins flashing red to indicate a severe hyperglycemiccondition, and the second text field 220 is changed to read “PRESS ANYBUTTON,” as seen in display status box D112. The microprocessor alsosends to the speaker 18 an audible prompt such as “To terminate alarmcondition press any button on the unit or say ‘OK.’”

During the time elapsed after the timer is set in step S152, themicroprocessor continuously checks to see if the timer has timed out.This is represented by the loop including steps S154 and S156. Asuitable time period is preferably about 10 seconds, and is preferablynot more than one minute. The purpose of this time period is to give theuser an opportunity to respond in a manner that indicates that the userhas not become disoriented because of the indicated severe hyperglycemiadetected by the blood test. If the user-patient presses any place on theinput device 102, or the microphone 22 picks up an audible signal thatvoice recognition software in the microprocessor recognizes as “OK,”before the time period expires, the microprocessor proceeds to the nextportion of the process, which is discussed further below.

However, if the timer times out before the patient responds, the unit 10responds at step S158 with an automatic call using the unit's internalcellular telephone 310 to 911 and to the subscriber service. These callscorrespond to the calls described above in connection with step S120.That is, the unit sends a prerecorded message to 911 and to thesubscriber service that identifies the caller, states that he or she isseverely hyperglycemic, and includes information on the unit's locationprovided by the GPS receiver 306, as discussed above.

If the user has responded before the time period set in step S152expires, the process proceeds to step S160, where the status of the flagis checked to determine if F=1. The process also proceeds to step S160if the user's blood glucose level is not greater than L4 as determinedin step S148. In either event, since F=0 (F≠1), the process proceeds tostep S162 where a time period is set. At the same time, the unit setsthe LCD display 200 as shown in display status box D114, with the LCDback lit in red to indicate an abnormal condition (in this case,hyperglycemia), with the star-shaped alarm icon 222 illuminated, andwith the message “GLUCOSE LEVEL HIGH” in the second text field 220. Theunit then awaits for the user to administer an insulin injection withinthe time period set in step S162. This is indicated by the loopincluding steps S164 and S166, during which the unit continuously checksto see if an insulin injection has been administered using the unit'sinsulin injection mechanism described above. The display screen 230 inFIG. 8 can be used at this point to indicate that the prescribedtreatment regimen is an insulin injection (not shown).

If the time period times out before an insulin injection is detected,the unit places a call to the subscriber service in step S168. This callis similar in nature to the call placed in step S158. That is, since thepatient responded if severe hyperglycemia was detected in step S148, oralternatively the patient is only mildly hyperglycemic as per step S144,the protocol of the present embodiment assumes that a life-threateningsituation is not present. Accordingly, the subscriber service willtypically telephone the user to determine if he or she is fully aware ofthe condition and has voluntarily chosen not to take action. In otherwords, this protocol judges that a call to 911 for immediate emergencyassistance is not warranted.

Administering an Insulin Injection

To activate the insulin injection mechanism 50, the patient moves themode switch slider image 108 a on the unit 10 to the left as seen inFIG. 5 to the “INJECT INSULIN” mode of operation. The microprocessor ROMcontains an algorithm that uses the patient's blood glucose reading, thetime elapsed since the previous insulin injection, and other pertinentinformation or parameters, to calculate the proper insulin dose. Whenthe results of a blood glucose test are available (see above), and themode switch button 108 a is in the INJECT INSULIN position, the insulindose calculated by the algorithm is displayed (not shown in the figures)in the numeric fields 232, 234 and 236 depicted in FIG. 7 in standarddose units of 0.01 cc each.

The UP and DOWN buttons (see FIG. 5) can be used by the patient tochange the amount of insulin to be injected. However, after the unitsets the dosage amount an attempt by the user to change it with the UPor DOWN button will trigger the unit's “dose lock” feature, which causesthe LCD display to display a prompt, such as “ARE YOU SURE YOU WANT TOCHANGE DOSAGE?” (not shown). In order to effect any change in the dosagecalculated by the unit's algorithm, the user must touch or press theSELECT button 102 d to override the dose lock feature. This dose lockfeature helps to prevent injection of inappropriate amounts of insulinby requiring the patient to confirm that he or she wants to override thedosage calculated by the unit. The healthcare community has recentlybegun to focus more strongly on the potential for medical errors in manyenvironments to have severe adverse effects on patients. The unit 10'sdose lock feature provides an effective way to prevent the occurrence ofserious insulin dosage errors in the environment of diabetes patients'self-monitoring and self-treatment of their symptoms.

Once the dosage amount has been set (either automatically by the unit'salgorithm or as manually adjusted by the patient after overriding thedose lock), the patient presses the SELECT button 102 d, which changesthe display so that the first and third numeric fields 232 and 236 areblank, the second numeric field 234 displays a “5,” the first text field238 displays the message “AWAITING INJECTION,” and the second text field240 contains the message “INSERT NEEDLE” (not shown in the figures). Themicroprocessor 300 can be programmed to provide a voice message to thespeaker 18 that repeats the message displayed in the second text fieldto provide a voice prompt to administer the injection.

If the patient has not done so already, he or she removes the cap 14 toexpose the hypodermic needle 52 and inserts the needle at an appropriatelocation to perform an intramuscular injection of insulin. The insulininjection mechanism preferably includes a sensor that senses when theneedle 52 has penetrated the patient's skin and begins a countdown inone-second intervals. The second numeric field 234 accordinglydecrements from “5” to “0,” during which time the injection mechanismadministers the prescribed insulin dosage that was previously displayed.The speaker 18 may accompany the visual countdown on the display with anaudible countdown. When the count reaches “0,” the second text fielddisplays the message “REMOVE NEEDLE” (not shown in the figures) and thesame message is repeated audibly by the speaker 18. When the needle isremoved, the injection mechanism provides a signal to the microprocessorindicating a completed insulin injection, which in turn triggers apositive response in step S164.

The time period set in step S162 should be of sufficient duration topermit the user to administer an insulin injection according to thisdescription. A suitable time period will preferably be about fiveminutes, but can be any appropriate time period between say, threeminutes and 10 minutes. If the unit detects an insulin injection beforethe time period expires, the LCD display 200 changes to the screen shownin display status box D116. It shows the detected blood glucose level asin display status box D114, and the second text field 234 in FIG. 7reads “RETEST BLOOD IN 15 MIN.” Next, the flag status is set to F=1 instep S170 and another time period is set to permit the user to completethe instructed blood test. The process then proceeds to step S174 toawait receipt of a blood sample within the allotted time, as representedby the loop containing steps S174 and S176. If no blood test is detectedwithin the allotted time, the unit proceeds to step S168, in which theunit places an automatic call to the emergency service provider so thatit can be confirmed that the user is not in danger. These steps S174,S176, and S168 are analogous to steps S130, S132, and S134 discussedabove, and the comments relating to that part of the process andpossible alternate embodiments, such as providing separate time periodsfor the waiting period and the blood testing operation, apply equallyhere.

In an alternate embodiment, the user manually controls the insulininjection using the input device 102. In this embodiment, moving themode switch 108 to the INJECT INSULIN position activates the inputdevice 102 to permit the user to confirm needle insertion and thecompletion of an injection. That is, instead of having a sensor thatsenses when the needle has penetrated the user's skin, the user simplypresses any place on the input device 102 to confirm that the unit is inposition to administer the desired insulin injection. Likewise, once theinjection is complete and the user has withdrawn the needle, pressingany place on the input device signals to the unit software that aninsulin injection is complete. While not as independent of user input asthe embodiment described above, an this alternate embodiment willundoubtedly prove less expensive to manufacture and thus be moreattractive economically for some users.

If a blood sample is taken within the allotted time, the process returnsto step S144. If the user's blood glucose level is within the normalrange, the process ends at step S146. However, if the patient is stillhyperglycemic after the insulin injection, the process proceeds to stepS148 to determine if the hyperglycemia is severe (blood glucose greaterthan L4). If so, step S150 determines that the flag status is F=1 (stepS170), and places an automatic call to the subscriber service in stepS178. This call will typically include information on the patient'sblood glucose level and indicate that an insulin injection has beenadministered within the preceding 15 minutes. The subscriber servicewill place a call to the user to confirm that he or she is not indanger.

If the patient's blood glucose level is only mildly elevated (that is,greater than L3 but not greater than L4), the process proceeds to stepS160, which detects that the flag status is F=1 (step S170). In thiscase, the unit terminates the process in step S180.

One of the advantages of being able to store and guide the user througha detailed treatment protocol like that depicted in FIG. 6 and describedabove is that it enables matching a patient's self-treatment protocol toinpatient treatment protocols. For example, if a detailed treatmentprotocol is determined for a particular diabetes patient in an inpatientsetting, this protocol can be duplicated by appropriate programming ofthe microprocessor of a unit according to the invention. Thisstreamlines the user's care and increases the utility of the unitbecause the user-patient's outpatient treatment protocol (using the unit10) and established inpatient treatment protocol will be essentially thesame. This can be expected to reduce the number of times the unitperforms emergency notifications, and likewise reduce the number oftimes a user must be taken to a hospital emergency room because his orher symptoms have become too severe for self-treatment.

Data Recording and Utilization

Another aspect of the invention involves storage in the microprocessor'sROM of complete information regarding the timing and results of theblood glucose testing, times and amounts of blood glucose producingsubstances ingested, times and amounts of insulin injections, calls to911 and the subscriber service, or any other aspect of the process justdescribed. For example, the unit can record the time of every glucosetest and the resulting glucose level. It can also record whether anyalarm condition was encountered. Likewise, the unit can further storeeach calculated insulin dosage, as well as the actual insulin dosageadministered by the patient and time of administration.

The patient's healthcare provider can download this information into acentral computer using the USB port 22 or a Wi-Fi connection, and employit for various reasons. For example, one important use of thisinformation is to make any necessary adjustments to the patient'streatment protocol, which can then be uploaded to the unit as discussedabove. The same information, collected from numerous patients, can beused for public health purposes by converting it to statisticalinformation on diabetes treatment.

This data can also have significant commercial uses. For example,diabetes is the subject of frequent clinical trials, which requirejudicious selection of test subjects to match the particularcharacteristic of the disease being studied in a given trial. This oftenrequires detailed knowledge of the treatment history of a potentialsubject, as well as his or her responsiveness to any given treatmentregimen. The storage of all of the above information regarding a user ofthe unit 10 greatly facilitates screening and selection of possiblesubjects for such clinical trials. Another possible use of the recordeddata would be to target training and informational materials specific toparticular aspects of the treatment and symptoms of groups of users. Forexample, a given group of users might be identified as having a certainclass of symptoms about which recent research has discovered newinformation. A healthcare provider could offer as a service thetransmission of messages (via cellular telephone) to those users whosetreatment profiles warrant. The message could be in the form of a noticefor display on the LCD displays of these users' units that additionalinformation they could find helpful or useful, or even critical, can befound at a certain website.

Those skilled in the art will recognize that other variations on thedisclosed embodiments that would fall within the scope of the inventionare possible. For example, even though the input devices 102 and 106provide a sleek, streamlined appearance to the unit, mechanical switchescan be used to perform the same functions. In another variation, thetesting/treatment history of a user can be downloaded via a bar codedisplayed on the LCD display 200 rather than by using an external USBdrive or an Internet connection. In this variation, the unit softwarecan include an algorithm that converts recorded data into a bar codeformat that is then displayed on the LCD display. Scanning the bar codetransfers the information to the scanning device. If necessary, theinformation can be contained in multiple bar code displays, which arethen scanned in turn.

In another alternate embodiment, the unit can include a removable USBstorage device on which the data is recorded. This will facilitatemanipulation and transportation of the recorded information. Forexample, it will eliminate an intermediate step in which the unit mustbe connected to a computer through a USB port, as discussed. It willalso enable a user to mail or otherwise transport the recorded data to ahealthcare provider, for those users not comfortable with transmittingdata over the Internet, as well as eliminating the need to visit thehealthcare provider simply to have the recorded data downloaded onto acomputer at the provider's location. If a removable USB storage deviceis used, the unit can be provided with multiple such devices so that theuser has a supply on hand.

Those skilled in the art will readily recognize that only selectedpreferred embodiments of the invention have been depicted and described,and it will be understood that various changes and modifications can bemade other than those specifically mentioned above without departingfrom the spirit and scope of the invention, which is defined solely bythe claims that follow.

1.-16. (canceled)
 17. A portable blood glucose monitoring device andinsulin administering pen integrated into a single unit for testing andtreating diabetes symptoms in a user, the unit comprising: a housing ofa size suitable for transport in a handbag or clothing pocket of theuser; a blood glucose monitoring system in said housing for receiving asample of the user's blood, said blood glucose monitoring system beingoperable to detect the glucose level in the blood sample; an insulinadministration mechanism in said housing for administering an insulindosage to the user; a microprocessor in said housing for determining ifthe detected blood glucose level is above a predetermined thresholdindicating that the user is in potential danger and calculating aninsulin dosage appropriate to the detected blood glucose level, whereinsaid insulin administration mechanism is operable to provide a signal tosaid microprocessor indicating that an insulin dosage has beenadministered; a display on said housing for displaying to the user atleast one of the detected blood glucose level and the calculated insulindosage; and a communication device in said housing and under the controlof said microprocessor for automatically informing a remote emergencyservice provider of a hypoglycemic condition of potential danger to theuser if said microprocessor (i) determines that the detected bloodglucose level is above the predetermined threshold, and (ii) fails toreceive said signal from said insulin administration mechanism within apredetermined time interval after said microprocessor determines thatthe blood glucose level is above the predetermined threshold.
 18. Adevice as in claim 17, further comprising: a mode switch in said housinghaving a first state for actuating said blood glucose monitoring systemto cause detection of the glucose level in the received blood sample anda second state for administering an insulin dosage; and at least onemanual input device operable by the user in conjunction with informationdisplayed on said display for providing a user interface permitting theuser to set an insulin dosage that is changed from the calculatedinsulin dosage displayed on said display, wherein when said mode switchis in said second state said insulin administration mechanism isoperable to administer the different insulin dosage if the calculatedinsulin dosage has been changed and to administer the calculated insulindosage if it has not been changed.
 19. A device as in claim 18, saidmode switch being manually operable between its first and second statesand said unit further comprising a sensor for sensing when saidadministration mechanism is in place for administering insulin, whereinmanually setting said mode switch to the second state automaticallyprovides a signal to said microprocessor to cause said insulinadministering mechanism to administer an insulin dosage when said sensorindicates that said administering mechanism is in place.
 20. A device asin claim 19, wherein said insulin administration mechanism includes ahypodermic needle for injecting the insulin dosage and said sensorsenses when said needle has penetrated the skin of the user.
 21. Adevice as in claim 19, wherein said mode switch has a neutral state andsaid microprocessor displays a prompt on said display instructing theuser to take a blood sample and detect the glucose level thereof whensaid mode switch is moved from its neutral state to its first state. 22.A device as in claim 19, wherein receipt by said microprocessor of asignal from said sensor when said switch is in the second state changessaid display to indicate a time interval after which the insulin dosagewill be automatically administered.
 23. A device as in claim 22, whereinsaid insulin administration mechanism includes a hypodermic needle forinjecting the insulin dosage and said sensor senses when said needle haspenetrated the skin of the user.
 24. A device as in claim 18, whereinsaid microprocessor further includes dose lock software that causes saiddisplay to display a prompt requiring the user to confirm the desire tochange the amount of insulin to be administered before permitting saidinsulin administration mechanism to administer the amount of insulininput by the user.
 25. A device as in claim 18, wherein: said devicestores information regarding a particular user's treatment requirementsand said microprocessor determines treatment regimens specific to theparticular user based on the detected blood glucose level and the storedinformation; said treatment regimens include (i) ingestion of at leastone blood glucose producing substance, if the detected blood glucoselevel indicates that the user is hypoglycemic, and (ii) administrationof insulin, lithe detected blood glucose level indicates that the useris hyperglycemic; and said microprocessor causes said display toindicate (i) an amount of the at least one blood glucose producingsubstance to be consumed, lithe detected blood glucose level indicatesthat the user is hypoglycemic, or (ii) the calculated insulin dosage, ifthe detected blood glucose level indicates that the user ishyperglycemic, or (iii) the different insulin dosage if the calculatedinsulin dosage has been changed.
 26. A device as in claim 17, whereinsaid communication device includes a cellular telephone and the remoteemergency service provider is at least one of a public emergency serviceprovider and an emergency service to which the user has subscribed. 27.A device as in claim 26, wherein said communication device is at leastone of (i) a cellular telephone separate from said housing and circuitrywithin said housing for establishing a wireless connection to saidcellular telephone, and (ii) cellular telephone circuitry within saidhousing.
 28. A device as in claim 17, further comprising circuitry insaid housing for detecting the location of the device, wherein saidcommunication device transmits information regarding the location to theremote emergency service provider.
 29. A device as in claim 28, whereinsaid circuitry for detecting the location of the device comprises a GPSreceiver.
 30. A device as in claim 17, wherein said device storesinformation regarding a particular user's treatment requirements andsaid microprocessor determines treatment regimens specific to theparticular user based on the detected blood glucose level and the storedinformation and displays the treatment regimens on said display.
 31. Adevice as in claim 30, wherein said treatment regimens include:ingestion of at least one blood glucose producing substance in an amountcalculated by said microprocessor based on the detected blood glucoselevel, if the detected blood glucose level indicates that the user ishypoglycemic; and administration of the calculated insulin dosagedetermined by said microprocessor based on the detected blood glucoselevel, if the detected blood glucose level indicates that the user ishyperglycemic.
 32. A medication administering device comprising: ahousing of a size suitable for transport in a handbag or clothing pocketof a user; a medication administration mechanism in said housing foradministering to the user a dosage of a medication contained in saidhousing; circuitry in said housing for controlling said medicationadministration mechanism; and a sensor for sensing when saidadministration mechanism is in place for administering a dosage, whereinsaid sensor automatically provides a signal to said circuitry to causesaid medication administering mechanism to administer a dosage when saidsensor indicates that said administering mechanism is in place.
 33. Adevice as in claim 32, further comprising a display on said housing,wherein said display indicates a time interval after which themedication dosage will be automatically administered.
 34. A device as inclaim 32, further comprising: a manually operable mode switch movable bya user between a first state and a second state, wherein said circuitryis responsive to said mode switch for disabling said medicationadministration mechanism when said switch is in said first state andpermitting said medication administration mechanism to administer adosage when said switch is in said second state; a manual input deviceoperable by the user to set a dosage to be administered by themedication administration mechanism; and a display on said housing forproviding a user interface displaying to the user the dosage input bysaid manual input device.
 35. A device as in claim 34, wherein receiptby said circuitry of a signal from said sensor when said switch is inthe second state changes said display to indicate a time interval afterwhich the medication dosage will be automatically administered.
 36. Adevice as in claim 34, wherein: said circuitry includes a microprocessorfor determining a medication dosage appropriate to information relatingto the user that has been provided to said microprocessor; said displayinitially displays to the user the dosage determined by saidmicroprocessor; and said manual input device is operable by the user inconjunction with the determined dosage displayed on said display forpermitting the user to set a medication dosage that is changed from thedetermined dosage and display the changed dosage on the display, whereinwhen said mode switch is in said second state said medicationadministration mechanism is operable to administer the different dosageif the determined dosage has been changed and to administer thedetermined dosage if it has not been changed.
 37. A device as in claim36, wherein said microprocessor further includes dose lock software thatcauses said display to display a prompt requiring the user to confirmthe desire to change the dosage before permitting said medicationadministration mechanism to administer the dosage input by the user. 38.A device as in claim 37, wherein said medication administrationmechanism includes a hypodermic needle for injecting the medication andsaid sensor senses when said needle has penetrated the skin of the user.39. A device as in claim 32, wherein said medication administrationmechanism includes a hypodermic needle for injecting the medication andsaid sensor senses when said needle has penetrated the skin of the user.40. A device as in claim 32, wherein the medication is insulin.